Rave Architect Lite. Instructor: [Name] About this Course. Audience. Prerequisites. Agenda. Purpose of the Course

Transcription

1 Rave Architect Lite Instructor: [Name] About this Course Audience Prerequisites Agenda Purpose of the Course

2 Audience All Clinical Data Management personnel using Rave except for Clinical Programmers Other Development personnel using Rave Prerequisites Intro to EDC EDC Business Process Training (online) EDC Study Specification course (online)

3 Agenda Section 1: Introduction General introduction to the terminology, processes, and tools used to build EDC studies for Roche-sponsored clinical trials Section 2: Building Studies In-depth, hands-on experience with using study specification to build a study in Architect Purpose of the Course Provide information that can be used to produce better study specifications for Roche-sponsored clinical trials that use Rave EDC, including: terminology, processes, and tools used by Clinical Programmers Roche standards, naming conventions, Clinical Programmer best practices, design considerations, and lessons learned Clinical programmers (CPs) rely on study specifications that are well written, precise, and thorough. By having hands-on experience with Architect in this course, you will better understand the necessity of properly-prepared study specifications.

4 Housekeeping Where are the toilets? When will we take breaks? Will my mobile phone or PDA be ringing? When can I answer my s?

5 Ground Rules Let s have fun Questions are welcome at all times Respectful and safe environment SDMs must attend the entire class to get credit Section 1: Introduction

6 Objectives for Section 1 In Section 1, you will be able to: Understand key study build concepts, such as: Rave Architect functionality Roche study build process Architect project components Roche Global Library Volume Launch Architect and explore a sample project: Projects, drafts, versions, and studies Draft items, including forms and fields, folders, dictionaries, matrices, edit checks, custom functions, derivations, and restrictions Lessons To Complete in Section 1 Lesson 1: Introduction to this Course Lesson 2: Key Rave Architect Concepts Lesson 3: Getting Started with Architect Lesson 4: Exploring Items in a Draft Lesson 5: Exploring Fields on a Form

7 Lesson 1: Introduction to this Course Participant Guide page 2 Topics To Cover in Lesson 1 About the Rave Architect Module What You Will Learn in the Architect Lite Training Sample Project Used in this Training

8 Medidata Rave Architect Module Medidata Rave Architect Module Software that Roche Clinical Programmers use to build studies in Rave Provides Clinical Programmers with a comprehensive, full-featured development environment in which to: build electronic case report forms (ecrfs), folders, and matrixes design all the elements on an ecrf, including fields, variables, data entry controls, labels, lists, help text, SAS labels, and so on write data logic for ecrf data, including data entry checks and edit checks that can trigger queries, stickies, and other actions specify role-based view and entry restrictions to EDC data copy standard elements from Roche s Global Volume create and manage separate development, testing, production, and training environments

9 Folders & ecrfs in the Demo Study Lesson 2: Key Rave Architect Concepts Participant Guide page 6

10 Topics To Cover in Lesson 2 Study Build Process Clinical Programmer Responsibilities Study Specifications for Building Studies Relationships Between Study Specifications and Finished Studies in the Rave Clinical Programmer Responsibilities CASA is a system role within Rave. Formerly, Clinical Programmers (CPs) at Genentech had the job title of Clinical Applications Systems Analyst (CASA) Responsibilities Technical support for Clinical Data Management in: clinical database development edit check programming Serve as a study configuration expert to Clinical Data Management and implement the study configuration in Rave If you understand what a CP sees in Architect: You will understand more about why and how the study specifications are written You will be able to more effectively develop and review study specifications for your study

11 Study Specifications Study Configuration Document (SCD) Mock ecrfs / ecrf Help Text / Source Document Verify (SDV) View & Entry Restrictions (VER) Study Logic and Check Specifications (SLACS) / Visit Form Matrix (VFM) Note: Unused functionality within Rave Architect is still captured as blank items in the study specifications documents (example: Open, Close, Start, and Stop functions of Subject Calendar). You have electronic copies of the SCD, VER, SLACS, and VFM on your system. The Mock ecrfs and SDV are printed handouts Study Specifications Item in Architect Forms Edit Checks Folders Custom Functions Patient calendar Primary matrix V&E Restrictions Automated Sticky Notes Comments on Audit Trail screen (for Labs only) TMS integration Analyte Specified in Mock ecrfs SLACS Visit/Form Matrix SLACS and Custom Functions Specification Document Visit calendar in Study Configuration Document Visit/Form Matrix View and Entry Restrictions SLACS SLACS Study Configuration Document and Integration Custom Functions Specification Mock ecrfs

12 Rave URLs Used at Roche Rave Projects Used at Roche

13 Lesson 3: Getting Started with Architect Participant Guide page 8 Topics To Cover in Lesson 3 Launching Architect Architect Main Screen Navigating Architect Projects and Associated Components Roche s Global Library Volume Exploring the Sample Project Hands-On Exercise

14 Rave Startup in the Training Environment Training URL: Login Credentials (case sensitive): Credential Pattern Example User casaal_n casaal_1 Password password3 password3 Navigation Tips Always use Rave buttons, tabs, and links to navigate the Rave interface. Do not use the buttons (Back, Forward, Stop, Refresh, or Home) or menu commands in your Web browser. If you use any of the browser buttons, Rave will prompt you to reenter your password before you can resume using Rave. Time-outs occur after a period of inactivity (45 minutes or more). Any unsaved data is lost when a time-out occurs You may be prompted to log in again The sidebar provides easy navigation to tasks or components that are relevant in the current context. Example: on the Draft page, the sidebar shows the types of items in the current draft.

15 Projects Contain the drafts, environments, subject search configurations, and copy source definitions Drafts contain ecrfs folders matrices edit checks other draft-specific elements When Clinical Programmers begin constructing a new EDC study for a Roche-sponsored clinical trial, they start by creating a new project in Architect P1 and P2 Projects P1 P2 Initial project Used for all system development Used for integration installation testing (also called P2 testing) Used for production

16 Environments A partitioned instance in the database for a particular purpose Name describes the context in which it is used Environments at Roche: Name DEV TEST TRAIN PROD Description Where Clinical Programmers create and configure EDC studies Where PDMs and project teams conduct online ecrf reviews and formal user acceptance testing (UATs) Where system users are trained Where the Rave EDC study is deployed live. Contains real clinical data gathered from actual study participants and is submitted to the FDA. Project Components 1. Create a Project 2. Create a Draft 3. Publish a Version 4. Push to a Study Environment

17 Drafts Form of the project that Clinical Programmers can view and edit Contains all the elements of a study that a Clinical Programmer can develop ecrfs, fields and variables, folders, data validations, and so on Clinical Programmers devote a lot of time to working on drafts of a project A project can contain multiple drafts Versions Saved snapshot of a draft, including all of the study elements that were configured in the draft at the time the version was created Shows how the study elements created in Architect will be displayed to users in the EDC module CRFs are associated with a specific version. The CRF version number is displayed at the bottom left of the ecrf screen. A project can contain multiple versions To create a new version, you publish a draft

18 Studies Electronic casebook that users can access and navigate in the Rave EDC module To create a new study that can be used in the Rave EDC module, you push a version to an environment Once a study is available in that environment, authorized users can access the study and enter data How These Components are Related

19 Roche s Global Library Volume Extensive collection of standard EDC study components Called Global Volume Integrated (GVI) in Architect Rather than build entire studies from scratch, Clinical Programmers can quickly assemble studies using pre-built components copied from the Global Library Volume Using elements in the global library adds efficiencies to study builds Using unchanged global standards eliminates the requirement to UAT these elements Hands-on Exercise for Lesson 3 See page 21 Answer the question in step 3

20 Answer for Hands-On Exercise The Primary Form for this draft is: Subject Identification form Lesson 4: Exploring Items in a Draft Participant Guide page 22

21 Topics To Cover in Lesson 4 Selecting Items to Explore Viewing Forms Viewing Folders Viewing Dictionaries Viewing Matrices Viewing Edit Checks Viewing Custom Functions Viewing Derivations Viewing Restrictions Hands-On Exercise Hands-On Exercise for Lesson 4 See page 38 Answer the questions for each step

22 Answers for Lesson 4 Hands-On Exercise 1. The form with the form OID value of PE2 is the Ongoing Physical Exam form. 2. The folder names for which no target values have been assigned are: Unscheduled and Concomitant Medications. 3. The folders that have the Visit Date form specified in the Primary Matrix are: Screening, Day 1, Week 2, and Week 3. Lesson 5: Exploring Fields on a Form Participant Guide page 39

23 Topics To Cover in Lesson 5 About Fields Selecting a Field on a Form Previewing Fields on a Form Viewing: Field Properties Variable Settings for a Field Field Help Text Field Edit Checks Verification and Review Settings View and Entry Restrictions Edit Checks Derivations Hands-On Exercise Hands-On Exercise for Lesson 5 See page 52 Answer the questions for steps 1 and 2

24 Answers for Lesson 5 Hands-On Exercise 1. Answers for COLD field: a. The correct variable format is: dd- MMM- yyyy b. No, it is not configured as a log field c. Yes, help text exists for this variable d. Two (2) field edit checks are configured for this field 2. Answers for TEMP field: a. True. The edit checks are system autoqueries b. Yes, this variable will be SDV d c. False. There are no view restrictions on this field. d. False. There are no entry restrictions on this field. 3. Answers for TEMPU field: a. False. There are no edit checks for this field. b. True. There are view restrictions on this field. c. False. There are no entry restrictions on this field. What Was Covered in Section 1 Overview of Rave Architect functionality Architect project components (projects, drafts, versions, and studies) Roche Global Library Volume Launching and Navigating Architect Exploring a sample project Exploring draft items, including forms and fields, folders, dictionaries, matrices, edit checks, custom functions, derivations, and restrictions

25 Where To Go From Here CDM Staff Continuing Onto Section 2 Return after the break Other Participants Training is complete Please sign the group training record Please complete the Course Survey: Course Name: Architect Lite Session 1 Please know that should you have issues you should delete your cookies. Section 2: Building a Study Participant Guide page 55

26 Lessons To Complete in Section 2 Lesson 6: Working with Projects, Environments, and Drafts Lesson 7: Copying Items from the Global Library Lesson 8: Building Forms Lesson 9: Creating Folders Lesson 10: Creating Matrices Lesson 11: Testing Your Progress Lesson 12: Defining Restrictions Lesson 13: Defining Edit Checks Lesson 14: Using Custom Functions Lesson 15: Finishing Touches Objectives for Section 2 In Section 2, you will learn how to: Create and configure projects, environments, and drafts Copy items from the Global Library Build forms for a study Configure folders and matrices for a study Publish a version, push it to a study, and see the results in the EDC Module Configure restrictions for forms and fields Configure edit checks and use custom functions Creating a draft in P2 from your P1 project

27 Lesson 6: Projects, Environments, and Drafts Participant Guide page 56 Topics To Cover in Lesson 6 Working with Projects Working with Environments Working with Drafts Hands-On Exercise

28 Ways to Create a Draft Create a Blank Draft Populate Using the Copy Wizard Copy from Pre-Existing Project Version Architect Loader Copy from Global Library (not used at Roche) Naming Conventions for Drafts Status-Release where Status = status of the protocol from which it was built Original Amendment Release = release number First release: R#, where # is a sequential number Subsequent releases if there is a change in a study after it goes to P2 but before go live: R#.#, where #.# is a sequential number The decimal point increments the number of times this has happened, such as R1.1, R1.2, and so on

29 How Drafts Are Named Demo and Hands-On Exercise for Lesson 6 See page 65

30 Lesson 7: Copying Items from the Global Library Participant Guide page 66 Topics To Cover in Lesson 7 About Copying from the Global Library Adding the Global Library as a Copy Source Running the Copy Wizard Searching for an Item in the Global Library Arranging ecrfs on the Forms Screen Hands-On Exercise

31 Leader Demo Running the Copy Wizard Copy a form How to check for the fields Copy an edit check Copy a derivation Hands-On Exercise for Lesson 7 See page 71

32 Lesson 8: Building Forms Participant Guide page 73 Topics To Cover in Lesson 8 About Forms (ecrfs) Copying Forms from the Global Library Creating Forms Editing Form Settings Deleting Forms Adding Fields to a Form Working with Dictionaries Working with Variables Specifying Help Text for Forms and Fields Hands-On Exercise

33 Mock ecrfs and Forms Naming Conventions for Forms Unique, descriptive name that indicates its purpose Form names are specified in the Mock ecrfs Form OIDs must be unique and are no more than six characters long (including digits) Studies must use standard form OIDs the form OIDs cannot be changed Forms with a similar purpose have the same root OID For coded forms, the Form OIDs have the same root as the form it is coding. Example: AEDEC

34 Dataset Conversion and Form OIDs When the SAS datasets are extracted from Rave, the datasets are combined under the following conditions: a Form OID is used more than one time, and the value ends in either a number or 'C' (for coded forms) Form OIDs Ending in a Number

35 Form OIDs and Coded Forms (Ending in a C ) Mock ecrfs and Fields

36 Naming Conventions for Fields Unique, descriptive name that indicates its purpose Field names are specified in the Mock ecrfs For field OIDs, Roche follows standard naming conventions Field OID is the SAS name Mock ecrfs and Dictionaries

37 Naming Conventions for Dictionaries and Entries DescriptiveName_V# where DescriptiveName is a brief name that indicates the purpose of the dictionary _V# is the version number of the dictionary being used For the Global Volume, this is always zero (0) If greater than zero, the dictionary represents a subset of what s in the Global Volume Dictionary entries use: User Data Strings: Mixed case and any keyboard characters. The values displayed on the screen in the EDC module in Rave. Coded Values: All-uppercase characters and spaces. Avoid special characters of any kind in coded values, including punctuation. Coded Values are what is stored. Coded values are what will be seen on Data Listing Reports, J-Review queries, or any other report that accesses the data. In most cases, the text value of the user data string and the coded value is the same. The exception is QOL questionnaires. Mock ecrfs and Variables

38 Naming Conventions for Variables Variable OIDs and Field OIDs are usually the same Exception: SAE Report Summary form Variable OIDs must be unique when two (or more) fields on different forms have the same field OID but different formats, or different dictionaries Variable settings are specified in the Mock ecrfs Mock ecrfs and Help Text

39 Leader Demo Build PE1 Form Build PE2 Form as described in the exercise Edit the MD1 Form Hands-On Exercise for Lesson 8 See page 88

40 Lesson 9: Creating Folders Participant Guide page 91 Topics To Cover in Lesson 9 About Folders Copying Folders from the Global Library Creating Study-Specific Folders Hands-On Exercise

41 Visit Form Matrix, Visit Calendar, and Folders Naming Conventions for Folders Unique, descriptive name that indicates its purpose Specified in the Visit / Form Matrix Roche uses the following guidelines: Maximum length of 50 characters Can have both upper and lower case characters. Cannot contain underscores, but may contain spaces or dashes. No more than one space or one dash is allowed between text characters. No spaces should be placed around dashes. No other special characters are allowed. If word abbreviations are required to conform to the 50 character limit, use abbreviations that are recognizable to others. Refer to the Table of Standard Abbreviations and a Table of Standard Folder Names and Folder OIDs in the Biometric Global Process Library. Double-check the standard to see whether the folder name has already been approved.

42 Naming Conventions for Folder OIDs Folder object IDs (OIDs) should be unique, brief, and descriptive Specified in the Visit / Form Matrix Roche uses the following guidelines for folder OIDs: Maximum of 10 characters long All uppercase text Cannot contain underscores, spaces, dashes, or any other special characters General conventions for new folder OIDs: Use the first letter of the event name followed by the number of the event. Example: Week 1 Day 3 would be W1D3 If the event is a single word it can be abbreviated. Example: Unscheduled would be UNSCH If the event is multiple words, use the first letter of each word. Example: End of Study would be EOS Refer to the Table of Standard Folder Names and Folder OIDs in the Biometric Global Process Library. Follow Along With the Instructor Copy folders from GVI Copy folders from Demo2010_D Edit calendar settings per specifications

43 Hands-On Exercise for Lesson 9 See page 95 Lesson 10: Creating Matrices Participant Guide page 96

44 Topics To Cover in Lesson 10 About Matrices Copying Matrices from the Global Library Volume Modifying a Matrix Creating a Matrix (Unscheduled Visit) Hands-On Exercise Types of Matrices Matrix Primary Matrix Add Event Matrix Master Matrix Study-specific Matrix Description Default matrix that is automatically created when a new subject is added Allows for adding more folders upon request, such as for unscheduled visits. Sites can add visits manually from a drop-down list Used to generate blank ecrfs and PDF files for annotated CRFs. Specifies the display order and identifies subject-level forms. The GVI includes a Master Form matrix. Used when you have two different cohorts in a single study. Each cohort uses a different matrix. Strategy to minimize extraneous folders for each subject.

45 Standard Matrices at Roche DNA or RCR Research Sample Consent Change Early Term Master Form Optional Research Sample Consent Change Pregnancy Report Primary Unscheduled Unscheduled Local Labs Visit Form Matrix and Matrices

46 Leader Demo Copy from Global Library Volume Editing the Draft Settings Hands-On Exercise for Lesson 10 See page 101

47 Lesson 11: Testing Your Progress Participant Guide page 103 Topics To Cover in Lesson 11 Publishing a Version from a Draft Pushing a Version to a Study Reviewing Your Results Making Subsequent Changes Hands-On Exercise

48 Naming Conventions for Versions CCC_R#.#_###_ddMMMyy_AAA Token CCC R#.# Description Environment where the version will be pushed (DEV, TRN, TST, or PRD) Draft from which the version was published ### Sequential number of versions published on that date ddmmmyy Date on which the version was created AAA Initials of the Clinical Programmer who created the version Roles for Reviewing Your Results Go to the EDC module and review the results of a pushed study The CASA-1 role provides unrestricted access so that Clinical Programmers can see the behavior of all the fields they build for later testing Clinical Programmers can run a report to view role-based functionality.

49 Follow Along With the Instructor Create a Version Hands-On Exercise for Lesson 11 See page 110

50 Lesson 12: Defining Restrictions Participant Guide page 111 Topics To Cover in Lesson 12 About Restrictions Configuring View and Entry Restrictions for a Form Configuring Field Restrictions Testing Restrictions Hands-On Exercise

51 Roles and Restrictions Role - Set of permissions to perform certain actions and access particular data Restriction - Controls the degree to which a given EDC role has access to forms or field Implications of Restrictions on Roles If a role is restricted from viewing a field or form, then users associated with that role: will not see that form or field in the EDC module will see blanks instead of restricted fields on reports in the Reporter module will not see any columns representing restricted fields in the data set, or they will see blanks instead of the restricted fields if a form contains restricted fields, and a form-level operation (such as a lock or freeze) is applied to the form, the operation does not apply to any restricted fields Default restrictions are included when you copy forms and fields from the Global Library Volume into your draft

52 View Entry Restrictions Settings on the Restrictions Screen Settings on the Restrictions screen include: whether the field requires verification (SDV) whether the field requires manual review (rare) which EDC role(s) can view or edit the field default value for field

53 Leader Demo Form Restrictions Publish and Push Hands-On Exercise for Lesson 12 See page 118

54 Lesson 13: Defining Field Edit Checks Participant Guide page 119 Topics To Cover in Lesson 13 About Edit Checks Configuring Field Edit Checks Hands-On Exercise

55 Field Edit Checks Built-in mechanisms that Rave provides for catching common data entry errors in fields Trigger system-generated queries for an individual field based on an error condition Examples: no data was entered in a required field entered data was non-conformant future date was entered in a date field data is out of a specified range Specified in the Study Logic and Check Specifications (SLACS) SLACS and Field Edit Checks

56 Types of Field Edit Checks Auto-Query for required data entry Auto-Query for non-conformant data Auto-Query for future date/time Auto-Query for data out of range Mark non-conformant data out of range (not used at Roche) Leader Demo Field Edit Check

57 Hands-On Exercise for Lesson 13 See page 122 Lesson 14: Edit Checks and Custom Functions Participant Guide page 123

58 Topics To Cover in Lesson 14 Working with Edit Checks Working with Custom Functions Hands-On Exercise SLACS and Edit Checks

59 Edit Checks and EDC Naming Conventions for Edit Checks Edit check names are: long and complex encoded with meaning so that, when you re looking through a long list of edit checks in Architect, you can learn at a glance a lot about an edit check without needing to open it Syntax [Scope][Type][Operation][C]_SASName_Description[_FolderSuffix] where the SASName is the field OID See page 124 in your Participant Guide

60 Check Steps and Check Actions Check Step Provide the logic statement for the edit check Check Action What the edit check will do if the conditions are met in the check step Problems with Edit Check Descriptions Errors, Omissions, and Ambiguities Syntax, Logic Errors Example: Date of Exam must be before Visit Date at Screening What s wrong? No field OIDs No folder OID No form OID for a cross form check The check description and message conflict slightly It is not clear what should happen if the dates are the same No check name provided

61 Types of Custom Functions standard and study-specific custom functions Copied from the Global Library Volume or standard project, along with the edit checks that fire them Defined in the study s custom function specification document integration custom functions Developed by Informatics and customized as needed to fit study-specific requirements Defined in the study s integration custom function specification document About Custom Functions Custom functions are called through the edit check engine They can: provide additional logic as part of the check steps, or they can provide more refined actions as part of the check actions, or both Custom functions are written in C Sharp code One of the edit checks you will copy in has a custom function attached to it

62 Leader Discussion In-Fix Notation Edit Check Logic Write PE Edit Check (Optional) Hands-On Exercise for Lesson 14 See page 136 Please answer the questions

63 Answers for Lesson 14 Hands-On Exercise Answers for Question 1: a. True b. False c. False d. False (Add Form Action) Answers for Question 5: a. PE2 b. Open a query c. Study-specific edit check d. Action field (this should be PED) Lesson 15: Finishing Touches Participant Guide page 139

64 Topics To Cover in Lesson 15 Creating a Draft in P2 from Your P1 Project Making Changes Late in the Development Cycle Hands-On Exercise Leader Demo Creating a Draft in a P2 project

65 Hands-On Exercise for Lesson 15 See page 141 What Was Covered in Section 2 Configuring projects, environments, and drafts Copying items from the Global Library Volume Configuring draft items, such as forms, folders, matrices, dictionaries, restrictions, edit checks, and custom functions Configuring fields on a form, including variables, help text, restrictions, and other settings Publishing a draft to a version, pushing a version to a study, and reviewing the results of a study in the EDC module Creating a draft in P2 from your P1 project

66 Where To Go From Here Training is complete Please sign the group training record Please complete the Course Survey: Course Name: Architect Lite Session 1 and Architect Lite Session 2 Should you have issues, you should delete your cookies. We Innovate Healthcare